REMS Compliance Auditor

United Biosource Corporation; United States; Remote; USD 65,000 - 90,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match

Discretionary PTO

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Discount programs

Job summary

United Biosource Corporation (UBC) is seeking a REMS Compliance Auditor to support risk evaluation and mitigation strategies across multiple client sites. The role involves coordinating with healthcare settings, pharmacies, and distributors to review audit questionnaires and document findings in project systems.

You will ensure audits meet REMS standards, maintain thorough documentation, and assist in training new hires. Remote, home-based position with potential on-site visits as requested.

Qualifications

• Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience.
• 1-2 years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry.
• Understanding of REMS guidelines and FDA regulatory requirements.
• Ability to work independently without supervision.
• Strong attention to detail and analytical skills.
• Proficiency in Microsoft Office suite.
• Strong organizational and time management skills.
• Willingness to learn and adapt to new processes and regulations.
• Ability to work efficiently and prioritize tasks effectively.
• Strong problem-solving abilities.
• Adherence to ethical standards and confidentiality protocols.
• Ability to maintain composure and professionalism under pressure.

Responsibilities

• Act as the primary REMS stakeholder point of contact with healthcare settings, pharmacies, and distributors.
• Maintain thorough and accurate documentation of all interactions.
• Review project-specific documentation, including audit plans and procedures.
• Complete timely reviews of assigned audit questionnaires per deadlines.
• Conduct document reviews to ensure REMS compliance.
• Follow up on audit documentation deficiencies and client timelines.
• Identify and address audit findings and report results to stakeholders.
• Record and report audit results and corrective actions.
• Collaborate with REMS Auditors to share best practices.
• Complete SOP reviews and client-specific training within timelines.
• Assist in developing project-specific documentation and training REMS Associate Auditors.
• Maintain professional communication across organizational levels.

Skills

Pharmacy auditing

Regulatory compliance

Attention to detail

Microsoft Office

Communication

Independent work

Time management

Problem solving

Confidentiality

Education

Associate degree

Bachelor’s degree preferred

Tools

Microsoft Office

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

REMS Compliance Auditor

Regular All Virtual Locations, Home Based Position, USA, Remote, US

As a pharmaceutical support industry leader , UBC is devoted to empoweringhealth solutions for a better tomorrow . We take pride in improving patient outcomes and advancinghealthcare. At UBC we provide services to enhance the entire drug development process andcommercialization lifecycle - From clinical trial support to real-worldevidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

GxP and/or healthcare industry experience highly preferred.

Job Title: YRC04G– REMS Auditor

Brief Description: The Risk Evaluation and Mitigation Strategy [REMS] Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. The REMS Auditor acts as a liaison with stakeholders such as healthcare settings, pharmacies, and wholesalers/distributors. This involves reviewing audit questionnaires, examining supporting documentation, and documenting all related information within project-specific applications. Through these efforts, the REMS Auditor ensures the smooth execution of audits while maintaining compliance standards and fostering effective communication with stakeholders. When necessary, this role involves supporting training for new hires, facilitating communication between the audit team and other internal and external teams and entities.

Specific job duties:

• Consistently provide effective communication to all relevant stakeholders as the primary point of contact for REMS stakeholders in healthcare settings, pharmacies, and wholesalers/distributors.
• Maintain thorough and accurate documentation of all interactions.
• Review project-specific documentation, including audit plans, procedures, and work instructions.
• Complete timely reviews of assigned audit questionnaires as per project deadlines.
• Conduct document reviews to ensure completeness, accuracy, and compliance with REMS program standards.
• Ensure timely follow-up on audit documentation deficiencies and actions as per client timelines, communicate via phone or email for outstanding documentation.
• Identify, evaluate, and address any audit findings, and articulate results to stakeholders.
• Accurately complete audit review forms to verify adherence to REMS program requirements.
• Formally record and report audit results, document corrective and preventive actions.
• Collaborate with REMS Auditors to share best practices.
• Complete SOP reviews and client-specific training within specified timelines consistently.
• Assisting in the development of project-specific documentation, including audit plans, procedures, and work instructions.
• Assisting in training REMS Associate Auditors in program audit techniques, ensuring thorough coverage of both project-specific and soft skills
• Maintain professional communication across all organizational levels, with clients, sponsors, and regulatory authorities.
• Manage multiple tasks and priorities according to business needs.
• Assist in reviewing audit questionnaires and supporting documentation to meet client time constraints.
• Collaborate with REMS Auditors to promote sharing of best practices.
• Conduct on-site audits as requested by clients.
• May support the Global Quality Compliance team with client and regulatory audits.

Supervisory Responsibility: No supervisory responsibility.

Desired Skills and Qualifications:

• Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience.
• 1-2 years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry.
• Understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [REMS] guidelines and FDA regulatory requirements and industry standards.
• Ability to work independently without supervision.
• Strong attention to detail and analytical skills.
• Proficiency in Microsoft Office suite.
• Strong organizational and time management skills.
• Willingness to learn and adapt to new processes and regulations.
• Ability to work efficiently and prioritize tasks effectively.
• Strong problem-solving abilities.
• Adherence to ethical standards and confidentiality protocols.
• Ability to maintain composure and professionalism under pressure.

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Hereare some of the exciting perks UBC offers:

• Remote opportunities
• Growth opportunitiesfor promotion
• 401K with companymatch*
• Discretionary PTO(Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, andvision coverage
• HSA/FSA
• Wellness program
• Adoption assistance
• Short termdisability
• Long term disability
• Life insurance
• Discountprograms

UBC is proud to be an equal opportunity employer anddoes not discriminate because of race, color, sex, age, national origin,religion, sexual orientation, gender identity and/or expression, status as aveteran, and basis of disability or any other federal, state, or localprotected class. We are committed to a diverse, equitable and inclusive culturethat fosters respect for each other, our clients, and our patients.